Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Neurological Disorders and Stroke (NINDS)
Funding Opportunity Title	NINDS Program Project Grant (P01)
Activity Code	P01 Research Program Projects
Announcement Type	New
Related Notices	August 5, 2013 - This PA has been reissued as PAR-13-312. March 25, 2011 - See Notice NOT-NS-11-014 Withdrawal of NINDS Participation in PAR-10-266.
Funding Opportunity Announcement (FOA) Number	PAR-11-172
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.853
FOA Purpose	This funding opportunity announcement (FOA) is issued by the National Institute of Neurological Disorders and Stroke to enable submission of program project grant applications that propose to conduct innovative, interactive research to answer significant scientific questions that are important for the mission of NINDS, via a synergistic collaboration between outstanding scientists who might not otherwise collaborate. The program project grant mechanism is designed to support research in which the funding of several interdependent highly meritorious projects as a group offers significant scientific advantages over support of these same projects as individual research grants.

Posted Date	March 22, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates apply
AIDS Application Due Date(s)	Standard dates apply
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	August 5, 2013 per PAR-13-312 (Original date: May 8, 2014)
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH s Applying Electronically website.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Program project grants (PPG) support investigator-initiated research programs, consisting of three or more highly interdependent projects, in which a team of investigators works in a clearly defined area of mutual scientific interest. In a program project, there should be a unifying, well-defined goal or targeted area of research to which each project relates and contributes, thereby producing a synergistic research environment that allows each research project to share the creative strengths of the others. The applicants should present a compelling case that support of interrelated projects and collaborating investigators will yield results beyond those achievable if each project were pursued separately and without formal interaction among the participating investigators. The applicants should explain why the program project is required to achieve the proposed research goals, i.e. why the goals of the component projects cannot be achieved without significant contributions from the other components. Examples of such contributions might be the sharing of ideas or data from other projects, the use of common assays or assessment methods across projects, and the shared use of specialized resources such as equipment, laboratories, or clinical facilities from the cores. Overall, the applicants should demonstrate a clear and compelling case that the component projects require one another and the shared core facilities.

In keeping with its tradition of strong support of investigator-initiated research, the NINDS expects the PPG director to define the integrating theme and to develop the approaches that would be used to accomplish the objectives of the proposed research program. The theme of a program project could be, for example, basic research on regeneration and plasticity in the nervous system or basic and clinical research on a specific disease process; the unifying concept could be an hypothesis concerning the fundamental mechanisms that result in the clinical manifestations of the specific disease process. Clinical trials of new interventions in patients are NOT appropriate for inclusion in a program project grant. Investigators who wish to conduct such trials should consult with the NINDS Office of Clinical Research (http://www.ninds.nih.gov/research/clinical_research/index.htm.)

Every component to be included in a PPG should be carefully considered. All projects that are included should be of the highest scientific and technical merit. All cores should provide resources that are essential to success of the goals of the PPG. The PPG director must be an established leader in scientific research with demonstrated capabilities in program direction. Regular meetings of participating investigators who share and evaluate results and new ideas are essential to the consolidation of the research projects into a cohesive program.

In summary, the following distinguishing features must be well documented in the program project application.

• There should be a clearly defined overarching goal or targeted area of research to which each component relates and makes essential contributions. It is expected that support of this set of interrelated projects and collaborating investigators will yield results that would not be achievable if each project were pursued separately and without formal interaction among the participating investigators.
  
  
• The PPG director should possess recognized scientific and administrative excellence, must make a substantial commitment of time and effort to the program, and must exercise leadership in the maintenance of its quality. The anticipated duties and responsibilities of the PPG Director should be clearly defined and an appropriate level of effort proposed;
  
  
• A PPG must contain a minimum of three component research projects. Each project should have significant and substantial scientific merit on its own as well as being an essential contributor to the central theme of the PPG;

Program projects are expected to involve the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All investigators should contribute to, and share in, the responsibilities of fulfilling the objectives of the PPG.

Funding Instrument	Grant.
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project. It is strongly recommended that potential applicants consult NINDS staff about their anticipated budget very early in the planning stage and a minimum of 12 weeks before submission of an application is anticipated.
Award Project Period	The maximum project period for these awards is 5 years. As per NOT-NS-08-010, there is a 10 year limit on the total project period for all NINDS P01 grants, so no more than one 5 year renewal award would be made.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Multiple PDs/PIs are not allowed in this FOA..

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Room 3201, MSC 9529
6001 Executive Boulevard
Bethesda, MD 20892-9529
(Rockville, MD 20852 for express/courier service)
Telephone: (301) 496-9223
Fax: (301) 402-0182
E-mail: [email protected]

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed:

• Overview of the Program Project: 12 pages
  
  
• Research Project Descriptions:
  Research Project Cover Page: 1 page
  Research Project Summary: 1 page
  Research Project Specific Aims: 1 page
  Research Strategy: 12 pages
  
  
• Core Descriptions:
  Core Unit Cover Page: 1 page
  Core Unit Summary: 1 page
  Core Unit Specific Aims: 1 page
  Core Unit Structure, Administration & Services: 6 pages

For Resubmission or Revision applications, also include the following:

Introduction (required for a resubmission or revision application)
For Overall P01: 1 page
For Each Research Project: 1 page
For Each Core Unit: 1 page

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

• The following guidelines supplement the instructions found in Form PHS 398. Additional instructions are required because Form PHS 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications. The Table of Contents should contain the headings outlined below for Section I (Preliminary Pages) and Section II (Research Plan). The Table of Contents should be paginated to enable reviewers to readily find specific information.

SECTION I: PRELIMINARY PAGES

1. Face Page (Form Page 1). Complete all items on the application's face page. For Item 2, enter the number of this FOA and the title, "NINDS Program Project Grant (P01) . Number succeeding pages consecutively.

2. Description: Project Summary and Relevance, Project/Performance Site(s), Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells (Form Page 2 and 2-continued). Describe briefly the proposed research program, indicate the research emphasis of the component Research Projects, and identify the purpose of the proposed Core units. List all Senior/Key personnel and Other Significant Contributors engaged on the project. Use continuation pages as necessary, numbering consecutively.

3. Table of Contents (Form Page 3): Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed project by project and core by core, the Table of Contents should enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and core. Each research project should be identified by number (e.g. Project I), title, and responsible Project Leader, and each Core should be identified by letter (e.g. Core A), title, and responsible Core Leader.

4. Budget Instructions (Form Page 4): Prepare a series of composite budget tables for the P01 grant as requested below, followed by a detailed budget for each Research Project component and each Core unit.

Budget Instructions for P01 Applications (Form Page 4)

A. Composite Budget.

• Use PHS-398 Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," to present the total budget for all requested support for the first year. For each category, such as "Personnel," "Equipment," etc., give the amount requested for each Research Project component and each Core unit, with subtotals.
  
  
• If consortium arrangements involving other institutions or organizations are anticipated, include total (direct and indirect) costs associated with such third-party participation in the Consortium/Contractual Costs category. Costs for purchased services should be itemized under the "Other Expenses" category.
  
  
• Use PHS-398 Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual Research Project component and Core unit budgets.

B. Budgets for Individual Research Project Components and Core Components

• Detailed Budget for Initial Budget Period (use PHS-398 Form Page 4 for each)
  
  
• Budget for Entire Proposed Project (use PHS-398 Form Page 5 for each)
  
  
• Budget Justifications and Explanations: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations.
  
  
• PLEASE NOTE: Consortium budgets (if applicable) should be presented as described in A, including budget for the entire proposed project period. Total direct and indirect costs of sub-awardees are to be shown under Consortium/Contractual costs on the individual component budget and a detailed sub-awardee budget is to be placed following the appropriate Research Project or Core budget.

5. Biographical Sketch (Biographical Sketch Format Page):

• Follow the instructions on the Biographical Sketch Format Page. This section should contain the biographical sketches of all individuals listed as Senior/Key Personnel and Other Significant Contributors, following the order listed on Form Page 2. Biographical sketches are required for all key personnel participating in the Research Project components and Core units. Begin with the P01 overall PD/PI and thereafter, in alphabetical order, submit biographical sketches as described in the Instructions for Form PHS-398.

6. Resources (Resources Format Page):

• Complete the "Resources" page of PHS-398 for the overall project. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

SECTION II - RESEARCH PLAN

Identify each Research Project component and each Core unit by title. Assign each Research Project component a Roman numeral (I, II, III) and assign each Core unit a capital letter (A, B, C) that reflects the order in which they are presented.

For each Research Project component and Core unit, provide the name of the responsible investigator, and biographical sketches for personnel not identified previously.

1. Overview of the Program Project (12 pages)

• A. History and Purpose of the Program. Discuss the overall P01 program's objectives and general plans for the proposed grant period, including research grant history with yearly funding level.
  
  
• B. Administration, Organization, and Operation. Include information on the support and commitment of the parent institution for the program, the authority of the PD/PI, the use of any proposed advisory committees, and space assignment. Describe organizational framework and provide an organizational chart. Advisory committees are not required. However, if an internal advisory committee is being proposed, members should be named and their letters of agreement included. In new applications, the expertise to be represented on any external advisory committee should be described, but potential members of the committee should NOT be named and letters from such individuals should NOT be included.
  
  
• C. Research Program. Discuss the proposed research program, highlighting its central theme. Describe the relationship between the projects and the Core units and their relationship to the central theme.
  
  
• D. Description of Assurances and Collaborative Agreements. Provide an overview and rationale for any collaborative and cooperative endeavors or subcontracts. Letters of agreement for these arrangements are included in Item 6. Letters of Assurance/agreement as described below.

2. Project Summary (12 pages for each Research Strategy component). Identify each project by a Roman numeral (I, II, III...) and a title. A full description of each project is to be provided following the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).

Begin the presentation of each Research Project component on a separate page, and include the following:

• A. Research Project Cover Page (1 page) with Title of Project, Name, Title, and Affiliation of Research Project Director /Principal Investigator, and then names titles, and affiliations of other investigators,
  
  
• B. Project summary (1 page; use PHS-398 Form Page 2): Discuss the purpose and nature of the project and its relevance to the program's overall theme.
  
  
• C. Research Plan (Begin each section with a section header and follow the format and instructions for Form PHS-398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).)
  Introduction to Application (1 page; resubmission or revision applications only)
  Specific Aims (1 page)
  Research Strategy (12 pages; Significance, Innovation, and Approach).

Indicate each Research Project's use of Core unit services, including why the core services are needed and the advantages and cost effectiveness of Core unit usage for the project.

For off-site projects, justification should be provided for the project's location, and plans for interaction and cooperation with the other components of the program should be addressed.

3. Core Units. Identify each proposed Core unit by a letter (A, B, C...) and a title (e.g., Molecular/Cellular Core, Imaging Core, etc.). A full description of each Core unit is to be provided following the format presented in Form PHS-398. Begin the presentation of each Core unit on a separate page. Include the following:

• A. Core Unit Cover Page (1 page) that includes the title of the core unit, and the name, title, and affiliation of the Core Project Director / Principal Investigator.
  
  
• B. Core Unit Summary (1 page; use PHS-398 Form Page 2): Include a Summary that identifies and describes the purpose of the proposed Core unit. Summarize the Core unit's overall objectives; highlight the decision-making process for use of Core services and plans for cost-effectiveness and quality control.
  
  
• C. Introduction (Resubmission or Revision Applications only; 1 page)
  
  
• D. Specific Aims (1 page)
  
  
• E. Core unit Structure, Administration, and Services Provided (6 pages). This section should also indicate the anticipated usage by each research project.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be postmarked on or before the due dates in Part I. Overview Information.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

NINDS will rarely, if ever, accept an application requesting more than 1 million dollars in direct costs per year. It is strongly recommended that potential applicants contact NINDS while they are still in the process of developing conceptual plans for a PPG and at least 12 weeks before submitting. After applicants have obtained agreement from the NINDS to accept the application, the PD/PI should include a cover letter with the application that identifies the NINDS staff member who agreed to accept assignment of the application.

This NINDS policy applies to all new, renewal, revision, or resubmission applications.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

The Impact/priority score of the overall PPG application will be evaluated by considering the scientific merit and inter-dependence of the projects, the quality of supporting cores, and the administrative structure of the overall program because, in a program project, there should be a unifying, well-defined goal or targeted area of research to which each project relates and contributes, thereby producing a synergistic research environment that allows each research project to share the creative strengths of the others. The application should demonstrate that support of interrelated projects and collaborating investigators will yield results beyond those achievable if each project were pursued separately and without formal interaction among the participating investigators. Reviewers will evaluate the strength of the information provided in the application that a program project is required to achieve the proposed research goals, i.e. why the goals of the component projects cannot be achieved without significant contributions from the other components and how the component projects require one another and the shared core facilities. Specific factors that will be evaluated in the consideration of the overall program project include:

• the scientific gain of combining the component parts into a program project (beyond that achievable if each project were to be pursued separately);
• the thematic cohesion of the program;
• the interrelationship of individual projects and cores;
• evaluation of the overall program in terms of significance, investigators (including leadership and scientific ability of the PD/PI and his/her commitment and ability to develop a well-defined central research focus), innovation, approach, and environment.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the PPG to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the PPG proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a PPG that by its nature is not innovative may be essential to advance a field.

Significance

Does the PPG address an important problem or a critical barrier to progress in the field? If the aims of the PPG are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the PPG? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the PPG PD/PI have the appropriate scientific and administrative qualifications and leadership ability to direct this program project? Is his/her commitment to the program adequate to ensure its success?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the PPG? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the PPG involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will combining the component parts into a program project lead to scientific gains that are substantially greater than those that would be achievable if each project were to be pursued separately? Is there thematic cohesion to the program? Is the interrelationship of individual projects and cores clear and scientifically well-justified? How will the administrative structure of the program, including any advisory committees, contribute to its probability of success? Does the application clearly describe and justify the proposed administrative and organizational structure? Is the proposed structure adequate to support and encourage optimal interactions among participants of the overall program? Does the administrative plan provide for internal quality control of ongoing research, management of day-to-day program activities and for fair and effective communication and cooperation among PPG members including resolution of disputes and allocation of funds?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the PPG proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed PPG involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the PPG.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the PPG. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the PPG proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for each project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the project contribute to the overall success of the program project?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Reviewers will not assign an impact/priority score or separate criterion scores for core unit components. Rather each core will be approved or disapproved. Approved cores will be given an adjectival level of enthusiasm. The following review criteria will be used for the evaluation of the individual Core units.

• Is the core necessary? Does it support at least two research projects?
• How is the core connected to the central focus of the overall program?
• How good are the facilities or services provided by the core (including procedures, techniques, and quality control)? Are they being used effectively?
• Are the core leader and key personnel well-qualified to provide the core service(s)? Are they committed to operating the core?
• If human subjects, vertebrate animals, or biohazards are to be used in a core, the adequacy of these sections will be assessed and will be considered in evaluating the individual core.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NINDS , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Alan L. Willard, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9248
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]

Ms. Tijuana Decoster, MPA
National Institute of Neurological Disorders & Stroke (NINDS)
Telephone: 301-496-9531
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.